Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03014999 |
| Other study ID # |
CNSexcit_SCI |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
June 2017 |
Study information
| Verified date |
June 2021 |
| Source |
Universidade Federal de Pernambuco |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A crossover trial with spinal cord injury volunteers will be conducted. Three sessions will
be performed once a week in a counterbalanced order and at least with seven days washout
period to minimize carry-over effects. In each session, volunteers will be submitted to
quantity and quality of sleep, type of eating, fatigue and motivation level, Ashworth scale
spasticity, cortical brain activity measures through simple pulse transcranial magnetic
stimulation (pTMS), spinal cord activity measures through electrical stimulation and
non-invasive brain stimulation (rTMS)
Description:
After given prior informed consent, volunteers will be submitted to three randomized and
counterbalanced sessions using a website (randomization.com) by a non-involved researcher. At
study beginning, volunteers will be evaluated through structured questionnaire and each
session, will comprise the following experimental sequence:
1. Quantity and quality of sleep: It will be enquired how many hours the volunteer slept in
the last night. The quality of the sleep will be measured through an analogue scale
graded from 0 (worst quality of sleep) to 10 points (best quality of sleep).
2. Type of eating: All the individuals will be asked about ingestion of food and drinks
that could change the cortical excitability (e. g.; coffee, chocolate, energetic, soda e
etcc). If positive, researchers will record the time since of ingestion and quantify the
amount of food.
3. Fatigue and motivation level: It will be measured through an analogue scale graded from
0 (lower fatigue or motivation levels) to 10 points (greater fatigue or motivation
levels).
4. Spasticity: It will be assessed by the modified Ashworth scale ranging from 0 to 4.
Performs the passive drive member to be measured and observing the time it arises the
resistance difficult the passive movement. This scale will be tested bilaterally in the
muscles of the lower limbs, the tested muscles are the quadriceps, adductors, hamstring,
dorsiflexors, hip flexors and flexors plant. The scale always applies by the same
evaluator.
5. Spinal cord activity: the level of excitability of spinal cord will be measured through
the following outcomes:
• Hoffman reflex (H reflex): the H reflex will be elicited by a percutaneous electrical
stimulation on tibial nerve delivered on popliteal fossa and recorded the
electromyographic responses from the soleus muscle. The values of maximal H reflex, M
wave and maximal H reflex and maximal M wave ratio (H/M ratio) will be obtained through
a recruitment curve.
The recruitment curve will start with a stimulus intensity delivered from 2 milliampere
(mA) and increasing on steps of 1 mA until to M wave curve stabilization (no increasing
of the M wave amplitude).
• Homosynaptic depression (HD): the HD will be obtained through a serie of two
consecutive stimuli separated by a interstimulus interval (from 30 ms until 10.000 ms).
The stimuli will be delivered on popliteal fossa and the electromyographic responses
from soleus muscle will be recorded. The stimuli will be delivered with the intensity
necessary to produce the maximal H reflex (this information will be available in the
recruitment curve as stated before). The difference between the first and the second
stimuli for each interstimulus interval will give rise to the recovery curve.
6. Cortical excitability: the cortical excitability will be measured through the motor
evoked potential (MEP) through simple pulse transcranial magnetic stimulation (BiStim2,
Magstim, UK) Initially, the higher cortical representation area (hotspot) of first right
dorsal interosseous (FDI) muscle will be determined through a figure-eight coil
connected to the magnetic stimulator held manually at 45 degrees from the midline, will
be placed over the right primary motor cortex (C3 - 10/20 System). Then, will be
determined the rest motor threshold (RMT) by finding the lowest stimulator output that
elicit motor evoked potential (MEP) at least 50 microvolts (μV). After determined the
RMT, the MEP value will be obtained through twenty suprathreshold (130% of RMT) stimuli
that will be delivered on primary motor cortex (C3).
7. rTMS: Initially, the higher cortical representation area (hotspot) of first right dorsal
interosseous (FDI) muscle will be determined through a figure-eight coil connected to
the magnetic stimulator (Rapid2, Magstim, UK) held manually at 45 degrees from the
midline, will be placed over the right primary motor cortex (C3 - 10/20 System). Then,
will be determined the rest motor threshold (RMT) by finding the lowest stimulator
output that elicit motor evoked potential (MEP) at least 50 microvolts (μV). After
determined the RMT, the coil will be positioned over the scalp (Cz - 10/20 System) and
based on previous studies will be performed rTMS protocols. Low frequency protocol: 1
hertz (Hz), 90% RMT, 1500 stimuli (1 train). High frequency protocol: 10 Hz, 90% RMT, 45
trains, 40 stimuli per train, inter interval of 28 seconds, 1800 stimuli. Sham rTMS will
be performed with low frequency protocol using two coils. The first one - connected to
the stimulator - will be positioned on a coil support close to the volunteer but not
visible. Therefore, characteristic stimulation noises will be audible. The second -
disconnected to the stimulator - will be placed over left primary motor area. After each
rTMS session, presence of adverse effects will be computed.
8. Spasticity: this evaluation will be performed immediately after (T0), thirty minutes
after (T1) and 1 hour after (T2) the rTMS. The procedures will be conducted following
the same protocol.
9. Spinal cord activity: this evaluation will be performed immediately after (T0), thirty
minutes after (T1) and 1 hour after (T2) the rTMS. The procedures will be conducted
following the same protocol.
10. Cortical brain activity: this evaluation will be performed after each revaluation of
spinal cord activity (T0, T1 and T2). The procedures will be conducted following the
same protocol.
